Randomized Trial of Vitamin B12 in Pregnant Indian Women
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Purpose
This study is a randomized, double-blind trial among 300 pregnant Indian women in order to determine the effectiveness of vitamin B12 supplementation in improving maternal B12 status. Secondary aims for this trial include maternal hemoglobin, maternal weight gain during pregnancy and infant birthweight. All women will receive standard of prenatal obstetric care, including routine supplementation with iron and folate.
| Condition | Intervention | Phase |
|---|---|---|
|
Pregnancy |
Dietary Supplement: Vitamin B12 Other: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Randomized Trial of Vitamin B12 in Pregnant Indian Women |
- Changes in maternal serum B12 concentration from 1st to 3rd trimester [ Time Frame: from 1st to 3rd trimester ] [ Designated as safety issue: No ]
- Changes in maternal hemoglobin levels, maternal weight gain and infant birth-weight. [ Time Frame: Maternal hemoglobin levels will be assessed at weeks 24 and 34 pre-pregnancy and at 6 weeks post-partum. Maternal weight gain will be assessed monthly until delivery and at 6 weeks post-partum. Infant birth-weight will be assessed at birth. ] [ Designated as safety issue: No ]
| Enrollment: | 366 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Vitamin B12
Vitamin B12
|
Dietary Supplement: Vitamin B12
Daily oral administration of 50 µg of Vitamin B12 taken from enrollment (at or before 14 weeks gestational age) until delivery
|
|
Placebo Comparator: Placebo
Placebo
|
Other: Placebo
Placebo taken daily from enrollment (at or before 14 weeks gestational age) until delivery
|
Detailed Description:
The incidence of poor fetal growth and adverse maternal and infant birth outcomes is quite high in India, and several lines of evidence suggest that maternal nutritional status may be an important factor. We have previously performed extensive evaluations of poor fetal and infant outcomes in other settings, and found that maternal micronutrient supplementation (B vitamins including vitamin B12, plus vitamins C and E) in HIV positive Tanzanian mothers decreased the risk of low birthweight (<2500 g) by 44% (RR (95% CI) 0.56 (0.38-0.82)), severe preterm birth (<34 weeks of gestation) by 39% (RR 0.61 (0.38-0.96)), and small size for gestational age at birth by 43% (RR 0.57 (0.39-0.82)). In a prospective cohort study of 410 pregnant Indian women, we recently found a strong relationship between maternal serum vitamin B12 concentration and risk of infant intrauterine growth retardation (IUGR). Compared to women in the highest tertile of serum B12 concentration, women in the lowest tertile were significantly more likely to have IUGR infants, after controlling for maternal age, weight, education, and parity (OR (95% CI) 5.98 (1.72-20.74)). We now propose a randomized, double-blind trial among 300 pregnant Indian women in order to determine the effectiveness of vitamin B12 supplementation (50 µg daily) in improving maternal B12 status. Secondary aims for this exploratory trial include maternal hemoglobin, maternal weight gain during pregnancy and infant birthweight. All women will receive standard of prenatal obstetric care, including routine supplementation with iron and folate. The study will be a collaborative effort between the Division of Nutrition, St John's Research Institute, Bangalore, India, and the Department of Nutrition, Harvard School of Public Health, Boston, US.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Pregnant women at or before 14 weeks gestational age.
Exclusion Criteria:
- Women who anticipate moving outside of the study area before study completion
- Those with twin or multiple pregnancies
- Those who test positive for hepatitis B (HepBSAg), HIV or Syphilis (VDRL)
- Those taking vitamin supplements in addition to folate and iron
- Those with a serious pre-existing medical condition, defined as conditions that require chronic or daily medical therapy such as connective tissue diseases, hypertension not related to pregnancy, inflammatory bowel disease, active tuberculosis, symptomatic heart disease, and insulin dependent diabetes.
Contacts and Locations| India | |
| St. John's Medical Research Institute, St. John's National Academy of Health Sciences | |
| Bangalore, Karnataka, India, 560-034 | |
| Principal Investigator: | Christopher P Duggan, MD, MPH | Harvard School of Public Health |
| Principal Investigator: | Anura Kurpad, MBBS, PhD | St. John's Research Institute |
| Principal Investigator: | Krishnamachari Srinivasan, MD | St. John's Research Institute |
More Information
Publications:
| Responsible Party: | Christopher Duggan, Associate Professor, Department of Nutrition, Harvard School of Public Health |
| ClinicalTrials.gov Identifier: | NCT00641862 History of Changes |
| Other Study ID Numbers: | HD052143 |
| Study First Received: | March 17, 2008 |
| Last Updated: | September 13, 2012 |
| Health Authority: | United States: Institutional Review Board India: Institutional Review Board |
Keywords provided by Harvard School of Public Health:
|
Pregnancy Maternal Nutritional Status Vitamin B12 |
Additional relevant MeSH terms:
|
Vitamin B 12 Hydroxocobalamin Vitamin B Complex Vitamins Micronutrients Growth Substances |
Physiological Effects of Drugs Pharmacologic Actions Hematinics Hematologic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013